Admira Protect

Primary DI
E22116501
Brand
Admira Protect
Company
VOCO GmbH
Model
1650
Catalog number
1650
Device description
Light-curing self-etch-bond reinforced with nano-fillers.Chemical-curing in areas inaccessible with a curing light.Futurabond DC achieves the same adhesive properties as total-etch preparations without seperate etching of the tooth substance.Moisture-tolerant.Durable marginal integrity.Easy and fast application - one-coat, one-cure technique.contains fluorides.No refrigerated storage needed.Ideal for paediatric use.
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBCSealant, Pit And Fissure, And Conditioner

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061823000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061823000ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSEVoco GmbH2006-07-21EBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E22116501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental unfilled resin sealant/coatingA non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius23 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags#

DUNS number
316699578
Device count
1
Lot or batch
true
Expiration date on label
true

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